A Study of the Gore VIABAHN BX for Treatment of Occlusive Disease in the Iliac Arteries.

Inclusion Criteria

• Patient is at least 18 years old;
• Patient is male, infertile female, or female of childbearing potential practicing an acceptable method of preventing pregnancy;
• Patient or legal representative is willing to give written informed consent;
• Patient is capable of complying with protocol requirements, including all follow-up visits;
• Patient has symptomatic claudication or rest pain without tissue loss (Rutherford Categories 2-4).
• Patient has de novo or restenotic target lesion(s) in the common and/or external iliac artery;
• Patient has one or more regions of stenosis ≥ 50% in the target vessel, based on visual estimate;
• Patient has a target vessel diameter visually estimated to be approximately between 5 mm and 13 mm;
• Patient has adequate ipsilateral blood flow including at least one sufficient ( 2.5mg/dL) and not on hemodialysis;
• Patient has a known hypercoagulability that cannot be corrected;
• Patient has evidence of a blood borne infection;
• Patient has had vascular access/catheterization in the lower extremity within 30 days of study enrollment;
• Patient has had a previous or planned coronary intervention within 30 days prior to enrollment in this study or required at time of study procedure;
• Patient has had a previous or planned bypass surgery in the target leg, or a bypass that occurs at the time of the index procedure;
• Patient is currently participating in this or another investigative clinical study.
• Patient has a stent or stent graft located within or immediately adjacent (≤5mm) to study lesion(s);
• Patient has evidence of angiographically visible thrombus within or adjacent to the target lesion(s);
• Patient has aneurysmal dilation proximal or distal to the target lesion(s) that would interfere with the placement of the device;
• Patient has a target lesion requiring atherectomy or any ablative device to facilitate stent delivery;
• Patient has a target lesion situated in such a way that an implanted device will prevent blood flow or perfusion to the internal iliac artery if patent.